BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512WWP PRDGM INSULIN PL EN

    MDR report key: 1040599 · Received May 9, 2008

    Report

    Report Number
    2032227-2008-00801
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND KETONES. NO BLOOD GLUCOSE READING WAS REPORTED. IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET SEVERAL TIMES, BUT THE HIGH BLOOD GLUCOSE LEVELS CONTINUED. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. A REPLACEMENT INSULIN PUMP WAS REQUESTED BY THE FAMILY AS THEY NO LONGER TRUSTED THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512WWP PRDGM INSULIN PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512WWP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization